5 Major Efficiency Boosts for Your Regulatory Operations

5 Major Efficiency Boosts for Your Regulatory Operations

WEBINAR ON DEMAND

5 Major Efficiency Boosts for Your Regulatory Operations

One of the key goals of RegOps leaders is to constantly improve efficiency of regulatory operations. It may be through process optimizations, improved toolsets, outsourced services or other means

 

About the webinar
  • This webinar will focus on 5 capabilities that a modern holistic RIM system can provide to greatly improve efficiency of regulatory data, content and process management and consequently incur substantial cost savings while retaining same or even increase the quality of final outputs
      About the speakers
      Renato Rjavec

      Renato Rjavec

      Director of Products

      As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

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      Get in touch

      Want to learn more about Amplexor and our industry-leading solutions? Drop us a line!

      Achieving effective, repeatable, risk-based pharma change control

      Achieving effective, repeatable, risk-based pharma change control

      Achieving effective, repeatable, risk-based pharma change control

      Most life sciences products continue to evolve long after approved formulations have entered the market, and all of these changes must be carefully tracked, managed and reported to maintain registrations, manufacturing transparency and patient safety.

      In addition to updates to the product itself, or to the location or equipment used in manufacture, changes could result from revised regulatory or legal requirements, a response to quality issues, or corrective actions after an audit. Other changes may come from the business environment, or internal strategy.

      Putting in appropriate change controls, guided via repeatable steps, also helps with identifying and containing any risk, which is important to maintain QA rigour and keep pace with legislation. It’s a fundamental expectation by regulators, in fact.

      ‘Change control’ refers to a systematic approach to managing all changes made to a product or a system – ensuring that no unnecessary changes are made; that all changes are documented; that manufacturing and distribution will not be unnecessarily disrupted; and that all resources are used efficiently. Usually, this will be handled within a pharmaceutical quality system.

      All pharmaceutical regulatory guidelines, including Good Manufacturing/Distribution Practice (GMP/GDP), cover change management. They specify regulatory notification and approval where required, and the need for post-change evaluation – to confirm that quality objectives were achieved at that, and that there was no unintended impact on product quality.

      Pain avoidance

      Beyond satisfying regulators and keeping patients safe, effective change control leads to improved cost and risk avoidance associated with deviations, complaints, recalls. Being proactive in understanding and planning for the potential impact of future changes, meanwhile, can lead to smoother implementations. Future changes can be factored in with less disruption to the manufacturing schedule, for instance.

      Conversely, a single inadequate change could lead to significant negative effects, including the release of a sub-standard product, potentially leading to product recall. A pattern of inadequate changes, meanwhile, could result in costly, time-consuming system remediation, not to mention the hidden costs of a loss of physician and patient confidence in the brand.

      The more proactive, pre-emptive and methodical companies can be, the lower these risks.

      What does good look like?

      A systematic approach to change control will leave nothing to chance, boosted by timely notifications to teams to complete tasks promptly. A good system will allow this kind of workflow to be automated, in compliance with given parameters – so that the QMS system or equivalent software assigns tasks and issues notifications, without someone having to remember to do this.

      So how can you evaluate the effectiveness of a risk-based change management system, if you’re implementing such a solution for the first time?

      Here are some useful features and attributes to look out for:

      • Controls to ensure that all proposed changes are formally evaluated, and a decision to accept or reject the proposal is documented, along with the related rationale.
        • The objectives, scope and the expected outcomes/benefits of any changes should be detailed too, so look for a system that provides for all of this.
      • The ability to include all relevant subject matter experts and appropriate internal or external stakeholders as applicable – those involved in the change proposal development and in the approval of the change.
        • Any impact on pending or approved filings and regulatory commitments will need to be considered and addressed as an integral part of the change control process.
      • Scope for risk-based classification, and support for a holistic impact assessment spanning product quality, documentation, cleaning, maintenance, regulatory compliance and so on.
        • The change management system should ensure that appropriate science- and knowledge-based risk assessments, by the subject matter experts, are performed and documented.
        • The level of formality and effort and documentation must be commensurate with the identified level of risk, both current and projected for the future.

      Contributing to better output

      Ultimately, change control is a quality system. It should never be reactive; rather it should be planned, intentional and purposeful, demonstrated via comprehensive documentation of decisions made and actions taken – and their justification. In fact, a good change management system should drive risk reduction to ensure better quality and manufacturing performance, boosted by continuous improvement and innovation.

      But this also assumes that teams understand their own obligations, their respective roles and responsibility in evaluating changes properly and ensuring that the entire process is seen through properly, and that everyone buys into it.

      Amplexor’s change control software provides the tools to monitor all types of changes that could influence the process, reliability or product quality; evaluate them in the context of regulatory requirements; and take them forward as appropriate, backed by appropriate documentation. Change information and approval within the system is transparent, and task tracking is intuitive and convenient, both for the manager and those performing the tasks.

      We also provide a workspace for SOP management, for all kinds of actually quality documentation, and associated processes – such as deviation management, complaints, out of specification results, audits, CAPA management and supplier qualification.

      In short, we’ve thought of everything so that you don’t have to.

      Vanja Primorac

      Vanja Primorac

      Life Science Consultant

      About the author

      Vanja Primorac is a life science consultant and QA specialist at Amplexor in Zagreb, Croatia, contributing to the development of and enhancements to the company’s software. A qualified pharmacist, she previously worked at GlaxoSmithKline as a QA Responsible Person and Senior Quality Executive.

       

      EU IDMP Implementation: DADI and the agile way forward ​

      EU IDMP Implementation: DADI and the agile way forward ​

      WEBINAR ON DEMAND

      EU IDMP Implementation: DADI and the agile way forward 

      Beginning of this year, European Medicines Agency (EMA) has finally broken cover and publicly confirmed the closed circle information and rumors spreading in the previous months: the DADI (Digital Application Dataset Integration) project will now serve as the ‘agile Plan’ to move forward with the implementation of regulatory data submissions as the way to achieve the planned PMS go-live.

       

      About the webinar

       In this webinar, we’ll discuss and learn about:

      • the DADI project and how it relates to the EU IDMP Implementation
      • our key takeaways – what DADI will support and won’t deliver
      • the impact of DADI on the industry 
      • how to respond to the change and adjust plans for a data-driven regulatory future if needed
        About the speakers
        Agnes Cwienczek

        Agnes Cwienczek

        ALSS Head of Product Management and Consulting

        Agnes has been in the position of ALSS Head of Product Management and Consulting since May 2017. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management.

        Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization.

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        Amplexor Life Sciences Product Update Q2/2022

        Amplexor Life Sciences Product Update Q2/2022

        WEBINAR ON DEMAND

        Amplexor Life Sciences Product Update: Q2/2022

         Watch this customer-exclusive webinar where you’ll be able to learn about our recent product enhancements and future plans. 

        The webinar will provide an in-depth view on some of the key features released in 7.0 including: 

        • IDMP data model with advanced data management
        • Redesigned submission planning, compilation and publishing
        About the speaker
        Renato Rjavec

        Renato Rjavec

        Director of Products

        As Director of Products, Renato is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last fifteen years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions for the global Life Sciences industry.

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        Amplexor Life Sciences Product Update Q2/2022

        Now that IDMP is real, is your RIM roadmap on the right track?

        WEBINAR ON DEMAND

        Now that IDMP is real, is your RIM roadmap on the right track?

        After all the preparations for IDMP, it’s here. But compliance will be a staged, iterative affair as requirements evolve.

        The key, then, is to establish whether your organization is on the right path to ensure long-term alignment with the demands of IDMP.

        About the webinar

        We’ll set out the most common scenarios pharma companies will typically be starting from, exploring the options in each case.

        Scenario 1: No formal RIM system currently in place
        Scenario 2: Existing RIM investment: build on it – or start afresh?
        Scenario 3: Single RIM vendor vs best-of-breed applications – can IDMP solution be implemented into the existing RIM landscape?

        In the webinar, we’ll work through each scenario, discussing the different options – and explore the merits of performing a low-risk/low-cost IDMP proof-of-concept alongside those existing RIM set-ups to check the preferred choice is fit for purpose.

        About the speakers
        Renato Rjavec

        Renato Rjavec

        As Director of Product Management, Renato is responsible for Amplexor’s Life Sciences product portfolio, focusing on customer value, innovation, quality and compliance. He has been with the company for 14 years, previously working on analysis, design, development and delivery of end-to-end regulatory and quality solutions for the Life Sciences industry.

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